From thrilling lab results to patent protection: can (poly)nucleotides and (poly)peptides sequences be protected by IP rights.

Patents
9 June 2023

Mireia Cama Sanchez

European patent attorney

What is more exciting for a biotech researcher than looking at four different letters in a seemingly random order? I’m talking about DNA, RNA, nucleotide sequences or nucleic acids to be specific. By extension proteins and polypeptide sequences (a bit less boring perhaps, twenty different letters in random order). Such sequences are considered the building blocks of life (i.e., biological material), and thus form the basis of many projects within the biotechnology, medicine, and other fields. As a researcher, you may have found a sequence that nicely fits your hypothesis, for example an improved promotor sequence, a modified protein with better stability or one that is highly active. You may wonder what is next and find yourself trying to answer questions like: “Does all this have a value beyond a publication in a scientific journal?”, “How can we let society benefit from this knowledge?”, “Can we use this to make a profitable product?”, “Can we patent polynucleotides or polypeptides, even if they are of human origin?” “If so, When and How do I have to protect the sequence?”

Can I get a patent for a polynucleotide or polypeptide?
Fortunately for the universities, institutes, and firms that actively work with gene fragments, vectors for expressing proteins, aptamers, primers, proteins, antibodies, etc., the answer to this question is: yes, absolutely! Even though polynucleotides and polypeptides constitute a type of biological material, they should not be considered different from other chemical compounds, as for example a small drug or a catalyst. They can be protected by means of Intellectual Property (IP) rights, mainly by means of patents. Besides their functional definition, they are also mostly structurally defined by their sequence of nucleotides or amino acids.

But maybe you have doubts about the possibility to patent your sequence. For example, the sequence you identified is identical to, or derived from, genes and proteins found in nature? Or they relate to a fragment of a human gene, and you realize this may be a sensitive topic. Why should we deserve to label them under our own name, and prevent others from using it without our permission?

Well, we cannot deny that these are also questions previously faced by national legislators. Nonetheless, most of the patent law systems allow this biological material to be patented even if the sequences previously occurred in nature.

Of course, there are particular requirements or provisions that apply. For example, in most of the countries it is required that the biological material is isolated from its natural environment or is produced by means of a technical process. Also, if we refer to a human gene, protein, or part thereof, the industrial application (viz. the intended use) of that isolated sequence or fragment is to be disclosed in an application for a patent. This and other requirements are stated in most of the patent legislations, including the European ‘Biotech Directive’ (93/44/EC) and the European Patent Convention that applies to most of the European countries [https://www.epo.org/about-us/foundation/member-states.html]. In other jurisdictions, such as in the USA, polynucleotides and polypeptides sequences are patent eligible if, let’s say, they are not identical to the sequences existing in the nature.

Thus, you deserve to get patent protection because you contributed to the development of technology.
At what stage should I protect my polynucleotide or polypeptide?
You should file a patent application prior to any other publication of the polynucleotide/polypeptides, their sequence(s) and/or their use, by any means (journal, presentation, lecture etc.).

Why do you need to do this before you publish? As is generally applicable to any invention, your polynucleotides or polypeptides and its sequence is required to be at least novel. In other words, if the sequence is already disclosed publicly somewhere else, you cannot validly protect it by means of a patent.
Don’t be discouraged though! The disclosure of a sequence somewhere else does not preclude a new use thereof, nor does it preclude a particular combination with other compounds to be the object of a patent. There are still many strategic opportunities to obtain a valid patent and a patent professional can help you identify these opportunities.

Besides the requirement of novelty, any invention also needs to be inventive, i.e. it needs to provide a technical contribution to the field in a non-obvious way. The concept inventive step is itself topic of a never-ending blog, so we won’t go into detail here. But we can summarize it by stating that your polynucleotide or polypeptide must involve a creative step beyond what is already commonly known. For example, it may provide an advantage, preferably unexpected, in relation to other sequences or compounds (e.g., improved promotor sequence, high specific antibody). Patent attorneys have a scientific background and are passionate about finding this inventive essence in your inventions and this will be an important point of discussion between you and them.

What can I do myself?
Novelty, and to a certain extent inventive step, can be checked by yourself. We encourage you to look into patent and non-patent literature , to see how your sequence compares to what is already disclosed. You may also stumble upon aspects that you may not have considered yet. For example, new comparative experiments with a closely related sequence to find that advantage that provides the inventive step, or ideas on how to further improve your sequence, or even new applications you had never thought of.

Let’s see now how to get patent protection:

The relevant question is how do we define the polypeptide/polynucleotide. By its sequence or not?
It is time to start thinking about the so-called scope of protection. In other words, what features of your polypeptide or polynucleotide are of highest importance and do you want to have protected, for example (part of) its sequence. This scope of protection is described in the so-called claims of a patent. The claims are written at the end of the patent document even though they are the most important part of the patent.

What is defined in the claims can be used by others to see what the metes and bounds are of your invention. Moreover, you can point at these claims and inform a competitor that they are infringing your patent.

A patent attorney will ask you many questions to identify these metes and bounds of your invention. To obtain a broad scope of protection, the patent attorney may for example ask if the working polypeptide or polynucleotide can be represented by several different sequences, or if the sequence can be altered at some points but still fulfills the same function. Perhaps you have identified that certain regions are essential, and others can be mutated without impacting the function. All these are important, as only defining an exact sequence in the patent opens the possibility for competitors to make a minor change and possibly escape the patent. The patent attorney may further ask how you envision the sequence to be used. For example, as reagent in a detection kit, or as therapeutic and for what medical indications.

Now, the take home message is, yes, you can protect your novel polypeptide or polynucleotide, and its sequence and variants in which you have been working for a long.

Last but not least, likely your intention around the polypeptide or polynucleotide includes also doing business. Importantly, other aspects of these molecules, such as the commercial name under which they are going to be sold alone or forming part of a kit, for example, can be (should be) protected by a different kind of IP figure, such as a registered trademark. - At AOMB we can help you with all the IP around your thrilling technology derived from that polynucleotide or polypeptide. Please contact one of our patent attorneys of the Life Sciences team.